Z-2284-2023Class II

Azurion 7 M20. X-ray Image guided Therapy System

Name: Z-2284-2023 Azurion 7 M20. X-ray Image guided Therapy System
Creator: Philips Medical Systems Nederland B.v.
Published: 2023-06-12
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-06-12 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 7 M20. X-ray Image guided Therapy System on 2023-06-12. FDA classified it as Class II and gives the reason as "The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2284-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-12
Posted: 2023-08-02
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 7 M20. X-ray Image guided Therapy System.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Root cause tag: design
FDA root cause: Component design/selection
Action: Customers were mailed a recall notification dated 6/8/23 notifying them of this medical device correction. Customers are asked to retain the correction notice until all on-site are corrected, ensuring they are available to those who operate the device. If cracks in the FlexMove Carriage and/or abnormal noise during transversal movements of the C-Arc are observed, customers are to contact Philips so their field inspection may be prioritized. A diagram of crack locations on the FlexMove Carriage was provided for user reference. Customers are asked to return the provided Response Form no later than 30 days from receipt. Philips will contact customers to schedule a visit to inspect on-site systems and coordinate replacement of the affected bolts and/or FlexMove Carriage, as needed. Customers with any questions may contact Customer Care Solutions at 1-800-722-9377. Philips sent an updated notification to customers on 11/15/2024 with updated information regarding continued use and actions planned by Philips. Systems may be safely continuing to be sued for at least three (3) years after completing the inspectional activities described in the Correction and Removal Actions of the provided letter and Philips will contact customers to schedule a visit to install the permanent solution ensuring that it is implemented within 3 years after the initial inspectional activities or after installation. The permanent solution expected to be available by December 2024. Customers were also instructed to complete and return the Response Form.
Quantity in commerce: 648 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.
Product codes and lots: Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75852749, 75855479, 75935287, 76078970, 76091821, 76138290, 76417103, 76479323, 76515054, 76553358, 76577152, 76787680, 76891085, 77121963, 77427180, 77530081, 77654726, 77654982, 77777427, 77779946, 77970791, 77970948, 77992050, 78105115, 78248928, 78294148, 78301055, 78397953, 78566369, 78742461, 78871714, 78951530, 79075848, 79092310, 79109133, 79112403, 79170704, 79221166, 79260136, 79386139, 79721725, 79755150, 79871193, 80031529, 80162299, 80389257, 80518631, 80634403, 80757669, 80864517, 80909985, 81158245, 81198118, 81435812, 81576136, 81585676, 82061620, 82084127, 83171264, 83616043, 84187167, 84817818, 86188742, 86497093, 86714680, 86796686, 87030322, 87184700, 87490196, 88006565, 88182534, 88520522, 88806300, 89171879, 89418260, 91702038, 92145971, 92904015, 93089744, 93184693, 93338682, 93496319, 93571818, 93617781, 93640291, 94453083, 94693032, 95022475, 95133121, 95182889, 95492390, 95747223, 95747224, 96447199, 96449972, 97171402, 97171408, 97385374, 97640203, 98542276, 98862191, 99584876,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2283-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-02
Z-2284-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-02

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)